Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments, 78602-78603 [2016-26913]

Download as PDF 78602 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices will be used to understand satisfaction among individuals who receive SHIP Medicare assistance/counseling, as well, as how the program can be improved to provide better service to its target population. Eighteen (18) unique states/ territories will be surveyed in FY 2017, with each state/territory expected to generate 75 unique responses, for a total of 1,350 individual responses in Year 1. This process will then be replicated in Year 2 (FY 2018) and Year 3 (FY 2019), with a different unique group of 18 states and territories being surveyed each year. By the end of FY19, SHIP will obtain 4,050 completed surveys to measure satisfaction at the state and national levels (18 states/territories × 75 responses per state × 3 years). SHIP will use the following factors to draw a representative sample of beneficiaries who received assistance/counseling: • Review counseling sessions at two points each year: Æ One week in the spring (outside of the annual Medicare Open Enrollment Period) Æ One week in the fall (during the annual Medicare Open Enrollment Period) • Focus only on non-redundant individuals (i.e., a random sample without replacement of individuals who receive SHIP counseling). • Randomly select 18 states and territories to be surveyed each year, with the states/territories stratified by data collection method* and the size of the Medicare-eligible population. * Data collection method refers to how each state/territory collects and enters its records of counseling sessions. The majority of states/territories (29 of 54) directly enter counseling records into SHIP’s National Performance Reporting (NPR) system, but the remaining states/ territories upload data in batches at the end of each month. To ensure that the batch upload states/territories will be able to pull weekly samples twice per year, we will limit these states/ territories to Years 2 and 3 of the survey administration period, thereby allowing for technical assistance to these states/ territories if necessary. To generate a sample with a 95% confidence level at the national level 384 responses will be required (n = 3,000,000 counseling sessions in 2015). SHIP anticipates collecting 75 completed surveys per state/territory, for a total collection of 4,050 completed surveys over the 3-year period. This larger collection will enable ACL to make state-to-state comparisons, which is an important feature of this survey. Specifically, state-to-state comparisons will allow ACL to identify which states/ territories are providing the best services to their beneficiaries, and what best practices can be shared across states/territories. The larger collection will also provide each state/territory with sufficient information to take local action to improve service within budgetary constraints. The proposed survey instrument may be viewed on the Web site: https:// www.acl.gov/Programs/CIP/OHIC/ index.aspx. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The average annual burden associated with these activities is summarized below: Respondent type Number of respondents Responses per respondent Average burden hours per response (hours) Total average annual burden (hours) Stratified Random Sample ............................................................................... 1,350 1 8/60 180 Dated: October 27, 2016. Edwin L. Walker, Acting Administrator and Assistant Secretary for Aging. [FR Doc. 2016–26924 Filed 11–7–16; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–3362] Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of availability; request for comments. mstockstill on DSK3G9T082PROD with NOTICES ACTION: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA’s ongoing collaboration SUMMARY: VerDate Sep<11>2014 16:27 Nov 07, 2016 Jkt 241001 with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions. DATES: Although you can comment on the PhUSE SDSP template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by January 9, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–N–3362 for ‘‘Intent to Review a Study Data Standardization Plan Template.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets VerDate Sep<11>2014 16:27 Nov 07, 2016 Jkt 241001 78603 Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. all matters regarding the use of the PhUSE SDSP template. FOR FURTHER INFORMATION CONTACT: II. Electronic Access Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993–0002, 301– 796–8856, crystal.allard@fda.hhs.gov. SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P FDA is a participating member of PhUSE, an independent, non-profit consortium of academic, regulatory, non-profit, and private sector entities. PhUSE provides a global platform for the discussion of topics encompassing the work of biostatisticians, data managers, statistical programmers, and e-clinical information technology professionals, with the mission of providing an open, transparent, and collaborative forum to address computational science issues. As part of this collaboration, PhUSE working groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. You can learn more about PhUSE working groups at https://www.phuse.eu/ cs-working-groups.aspx. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.) In December 2014, FDA published the Study Data Technical Conformance Guide (the ‘‘Guide,’’ available at https:// www.fda.gov/ForIndustry/ DataStandards/StudyDataStandards/ default.htm), which contains technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format. In section 2.1 of the Guide, FDA recommends that sponsors should include a plan (e.g., in the IND) describing the submission of standardized study data to FDA. FDA’s Study Data Standards Resources Web page provides recommendations for preparing an SDSP (https://www.fda.gov/ downloads/ForIndustry/DataStandards/ StudyDataStandards/UCM447119.pdf). FDA now intends to review the PhUSE SDSP template, a deliverable of the working group effort described previously in this document, with the potential result that FDA could recommend the use of the template in its current form, or in a modified form, for use in the regulatory submission of study data in conformance with the Guide. FDA invites public comment on Frm 00039 Fmt 4703 Dated: November 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–26913 Filed 11–7–16; 8:45 am] I. Background PO 00000 The PhUSE SDSP template is available at: https://www.phusewiki.org/ wiki/images/e/ea/SDSP_Template.pdf. Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0743] Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.’’ This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov/ will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78602-78603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26913]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3362]


Intent To Review a Study Data Standardization Plan Template; 
Notice of Availability; Establishment of a Public Docket; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research, is establishing a public docket to collect 
comments related to a proposed Study Data Standardization Plan (SDSP) 
template. As part of FDA's ongoing collaboration with the 
Pharmaceutical Users Software Exchange (PhUSE), an independent, non-
profit consortium addressing computational science issues, a PhUSE 
working group developed the PhUSE SDSP template. The purpose of this 
review is to evaluate the template and determine whether FDA will 
recommend its use either as is, or in a modified form, for regulatory 
submissions of study data. FDA is seeking public comment on the use of 
the PhUSE SDSP template for regulatory submissions.

DATES: Although you can comment on the PhUSE SDSP template at any time, 
to ensure that the Agency considers your comments in this review, 
please submit either electronic or written comments by January 9, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 78603]]

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-3362 for ``Intent to Review a Study Data Standardization 
Plan Template.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Crystal Allard, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301-
796-8856, crystal.allard@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is a participating member of PhUSE, an independent, non-profit 
consortium of academic, regulatory, non-profit, and private sector 
entities. PhUSE provides a global platform for the discussion of topics 
encompassing the work of biostatisticians, data managers, statistical 
programmers, and e-clinical information technology professionals, with 
the mission of providing an open, transparent, and collaborative forum 
to address computational science issues. As part of this collaboration, 
PhUSE working groups develop and periodically publish proposals for 
enhancing the review and analysis of human and animal study data 
submitted to regulatory agencies. You can learn more about PhUSE 
working groups at https://www.phuse.eu/cs-working-groups.aspx. (FDA has 
verified the Web site addresses as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over 
time.)
    In December 2014, FDA published the Study Data Technical 
Conformance Guide (the ``Guide,'' available at https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm), which 
contains technical recommendations to sponsors for the submission of 
animal and human study data and related information in a standardized 
electronic format. In section 2.1 of the Guide, FDA recommends that 
sponsors should include a plan (e.g., in the IND) describing the 
submission of standardized study data to FDA. FDA's Study Data 
Standards Resources Web page provides recommendations for preparing an 
SDSP (https://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM447119.pdf).
    FDA now intends to review the PhUSE SDSP template, a deliverable of 
the working group effort described previously in this document, with 
the potential result that FDA could recommend the use of the template 
in its current form, or in a modified form, for use in the regulatory 
submission of study data in conformance with the Guide. FDA invites 
public comment on all matters regarding the use of the PhUSE SDSP 
template.

II. Electronic Access

    The PhUSE SDSP template is available at: https://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf.

    Dated: November 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26913 Filed 11-7-16; 8:45 am]
BILLING CODE 4164-01-P
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